PlainRecalls
FDA Drug Moderate Class II Terminated

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

Reported: July 3, 2019 Initiated: June 24, 2019 #D-1429-2019

Product Description

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

Reason for Recall

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Details

Units Affected
40 bottles
Distribution
Nationwide Within the United States
Location
Grover Beach, CA

Frequently Asked Questions

What product was recalled?
Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04. Recalled by H J Harkins Company Inc dba Pharma Pac. Units affected: 40 bottles.
Why was this product recalled?
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which agency issued this recall?
This recall was issued by the FDA Drug on July 3, 2019. Severity: Moderate. Recall number: D-1429-2019.